Renal ImpairmentPhase 1NCT05927415
A Study to Test How Kidney Problems Influence the Blood Concentrations of Efgartigimod
A Phase 1 study testing Efgartigimod IV in people with Renal Impairment, run by argenx at 2 sites in Germany.
Trial summary
A study to test how kidney problems influence the blood concentrations of efgartigimod Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment
- What is being tested?
- Efgartigimod IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesGermany
- Study dates
- 17 Jul 2023to 12 Jun 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant is at least 18 and ≤80 years of age when signing the informed consent form, and willing and able to understand and comply with the requirements of the study
- Participant has BMI ≥18.0 and ≤38.0 kg/m2
- Female participant of childbearing potential agrees to contraceptive use consistent with local regulations for clinical studies and has a negative serum pregnancy test
- Participant has a stable diagnosis of RI, without any significant change in overall disease status in the 3 months before screening
- At screening, the participant has eGFR (mL/min) calculated using the CKD-EPI equation that is within the following ranges: 60 to <90 (mild RI); 30 to <60 (moderate RI); <30 (severe RI not requiring dialysis); ≥90 (normal renal function)
- Participant has normal or not clinically significant findings in physical examination, vital signs, ECG, and clinical laboratory evaluations; exceptions may be granted for findings consistent with the participant's RI or other related stable diseases
- Absence of clinically significant illness and surgery during the 4 weeks before the infusion and absence of clinically significant history of hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, and immunologic disease
- Participant with RI is receiving a stable medical regimen for 14 days before the efgartigimod infusion, except for routine daily management of electrolytes (eg, potassium), acid-base, or other electrolyte abnormalities associated with RI. Control participant agrees to not receive any medications, except contraceptives and occasional paracetamol use
Who cannot join
- Participant has previously participated in an efgartigimod clinical study and received at least 1 dose
- Participant has a known hypersensitivity to 1 of the components in efgartigimod IV or a history of severe allergic or anaphylactic reactions
- Participant has a condition except for RI that could affect efgartigimod PK
- Participant has a clinically significant unstable medical condition or history of any illness that can increase the risk associated with study participation or efgartigimod administration or can interfere with the interpretation of study results and make the participant inappropriate for this study.
- Participant has a positive nasopharyngeal swab test for SARS-CoV-2 on day -1
- Participant has supine 12-lead ECG abnormalities at screening considered clinically significant and clinically significant vital sign abnormalities
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- Participant has a history of significant drug or alcohol abuse within 6 months before screening, or positive urine drug screen or alcohol test at screening
- Participant has a history of malignancy unless considered to be cured by adequate treatment with no evidence of recurrence for ≥3 years before the efgartigimod infusion. Participants with the following cancers can be included at any time, provided they are adequately treated before they participate in the study: Basal cell or squamous cell skin cancer, Carcinoma in situ of the cervix, Incidental histological finding of prostate cancer
- Participant has a clinically significant active or chronic, bacterial, viral, or fungal infection at screening, including a positive serum test at screening for active infection with any of the following conditions: HBV indicative of an acute or chronic infection unless associated with a negative HBsAg or negative HBV DNA test, HCV based on HCV antibody assay unless an RNA test indicates the participant is HCV negative, HIV based on CD4 count <200 cells/mm3 associated with an AIDS-defining condition, HIV based on CD4 count greater than 200 cells/mm3 not adequately treated with antiretroviral therapy
- Participant has participated in a clinical study involving the administration of an IMP or marketed drug or device within 30 days of the infusion, administration of a biological product in the context of a clinical study within 90 days of the infusion, or concurrent participation in an investigational study involving no drug or device administration
- Participant is an employee of the investigator or study site with direct involvement in this clinical study or other studies under the direction of the investigator or study site or a family member of an employee of the investigator
- Female participant has a positive pregnancy test before dosing or is pregnant or breastfeeding
- Participant has had a renal transplant
- Participant has received any new prescription medication before the efgartigimod infusion or other medication, except those approved by the investigator
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
CRS Clinical Research Services Kiel GmbH
Kiel, 24105
APEX GmbH
Munich, 81241
About this study
Official title: A Phase 1, Open-label, Study to Evaluate the Pharmacokinetics of Efgartigimod IV 10 mg/kg Single Dose Administered in Participants With Renal Impairment
A study to test how kidney problems influence the blood concentrations of efgartigimod
- Conditions
- Renal Impairment
- Being tested
- Efgartigimod IV
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efgartigimod IVBiological
Intravenous infusion of efgartigimod
| Study group | Role | What they receive |
|---|---|---|
| Mild renal impairment | Experimental | Patients with 60 <= eGFR <90 Receives: Biological: Efgartigimod IV |
| Moderate renal impairment | Experimental | Patients with 30 <= eGFR <60 Receives: Biological: Efgartigimod IV |
| Severe renal impairment | Experimental | Patients with eGFR <30 Receives: Biological: Efgartigimod IV |
| Normal renal function | Experimental | Patients with eGFR >=90 Receives: Biological: Efgartigimod IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efgartigimod PK parameters (Cmax)
Measured: up to 64 days
Secondary outcomes (4)
Efgartigimod urine concentrations
Measured: up to 64 days
Incidence of serious adverse events
Measured: up to 64 days
Reduction from baseline in total IgG levels over time
Measured: up to 64 days
Incidence of ADA to efgartigimod
Measured: up to 64 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start17 Jul 2023
- Primary completion12 Jun 2024
- Study completion12 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ImpairmentStudies of the same condition, open and under way.
- More trials run by argenxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927415
- Sponsor's protocol ID
- ARGX-113-2201
- Status last verified
- Jun 2024
- First submitted
- 22 Jun 2023
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Study to Evaluate the Pharmacokinetics of Efgartigimod IV 10 mg/kg Single Dose Administered in Participants With Renal Impairment
- ClinicalTrials.gov ID
- NCT05927415
- Acronym / sponsor ID
- ARGX-113-2201
- Conditions
- Renal Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- argenxIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 12 Jun 2024 (actual)
- Study completion
- 12 Jun 2024 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to test how kidney problems influence the blood concentrations of efgartigimod
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mild renal impairment | Experimental | Biological: Efgartigimod IVPatients with 60 <= eGFR <90 |
| Moderate renal impairment | Experimental | Biological: Efgartigimod IVPatients with 30 <= eGFR <60 |
| Severe renal impairment | Experimental | Biological: Efgartigimod IVPatients with eGFR <30 |
| Normal renal function | Experimental | Biological: Efgartigimod IVPatients with eGFR >=90 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participant is at least 18 and ≤80 years of age when signing the informed consent form, and willing and able to understand and comply with the requirements of the study
- Participant has BMI ≥18.0 and ≤38.0 kg/m2
- Female participant of childbearing potential agrees to contraceptive use consistent with local regulations for clinical studies and has a negative serum pregnancy test
- Participant has a stable diagnosis of RI, without any significant change in overall disease status in the 3 months before screening
- At screening, the participant has eGFR (mL/min) calculated using the CKD-EPI equation that is within the following ranges: 60 to <90 (mild RI); 30 to <60 (moderate RI); <30 (severe RI not requiring dialysis); ≥90 (normal renal function)
Key exclusion criteria (14 listed)
- Participant has previously participated in an efgartigimod clinical study and received at least 1 dose
- Participant has a known hypersensitivity to 1 of the components in efgartigimod IV or a history of severe allergic or anaphylactic reactions
- Participant has a condition except for RI that could affect efgartigimod PK
- Participant has a clinically significant unstable medical condition or history of any illness that can increase the risk associated with study participation or efgartigimod administration or can interfere with the interpretation of study results and make the participant inappropriate for this study.
- Participant has a positive nasopharyngeal swab test for SARS-CoV-2 on day -1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efgartigimod IVIntravenous infusion of efgartigimod | Biological | Mild renal impairment, Moderate renal impairment, Normal renal function, Severe renal impairment |
Primary outcome
Efgartigimod PK parameters (Cmax)
Time frame: up to 64 days
4 secondary outcomes
Efgartigimod urine concentrations
Time frame: up to 64 days
Incidence of serious adverse events
Time frame: up to 64 days
Reduction from baseline in total IgG levels over time
Time frame: up to 64 days
Incidence of ADA to efgartigimod
Time frame: up to 64 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Efgartigimod IV in people with Renal Impairment, run by argenx at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efgartigimod PK parameters (Cmax) (time frame: up to 64 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.